Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.
Interventions
DRUGinsulin detemir
For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Type 1 or type 2 diabetes mellitus
Exclusion criteria
* Subjects who are unlikely to comply with the protocol * Subjects who are currently being treated with Levemir® * Subjects who previously were enrolled into the study * Subjects with hypersensitivity to Levemir® or any of its excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse drug reactions (SADRs) | during treatment |
| Major hypoglycaemic events | during treatment |
Secondary
| Measure | Time frame |
|---|---|
| Number of all hypoglycaemic events | the last 4 weeks of treatment |
| Weight changes | after 12 weeks |
| Number of serious adverse events | during treatment |
| Variability in fasting blood glucose (FBG) and average plasma glucose level | after 12 weeks |
| HbA1c | after 12 weeks and 26 weeks of treatment |
| Number of all adverse events | during treatment |
Countries
Indonesia
Outcome results
None listed